According to the drug's manufacturer, Bristol-Myers Squibb, the FDA based its approval on the results of two clinical trials involving 516 people hospitalized for bipolar disorder. The studies showed that Abilify significantly improved mania symptoms or mixed episodes.

The most common side effects were restlessness, constipation, and accidental injury. Nearly 11% of those who received Abilify for mania discontinued use of the drug due to side effects compared with 9% of those on a placebo.